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[Blue Journal在线发表]:ARDS最大复张肺开放通气
2019年11月23日 时讯速递, 进展交流 暂无评论

Maximal Recruitment Open Lung Ventilation in Acute Respiratory Distress Syndrome (PHARLAP): A Phase II, Multicenter, Randomized, Controlled Trial

Hodgson CL, Cooper DJ, Arabi Y, et al

Am J Respir Crit Care Med. 2019 Jul 29.doi: 10.1164/rccm.201901-0109OC.

RATIONALE: 背景

Open lung ventilation strategies have been recommended in patients with acute respiratory distress syndrome (ARDS).

推荐ARDS患者采用肺开放通气策略。

OBJECTIVE: 目的

To determine whether a maximal lung recruitment strategy reduces ventilator-free days in patients with ARDS.

确定最大肺复张策略能否缩短ARDS无机械通气天数

METHODS 方法

A phase II multicenter, randomized, controlled trial in adults with moderate to severe ARDS. Patients received either maximal lung recruitment, titrated positive end expiratory pressure and further tidal volume limitation or control 'protective' ventilation.

针对中重度ARDS患者的II期多中心,随机,对照试验。患者分别接受最大肺复张,滴定PEEP并进一步限制潮气量,或接受“保护性”通气。

MEASUREMENTS: 预后指标

The primary outcome was ventilator-free days at day 28. Secondary outcomes included mortality, barotrauma, new use of hypoxemic adjuvant therapies, ICU and hospital stay.

主要预后指标为28天时无机械通气天数,次要预后指标包括病死率,气压伤,新使用辅助治疗,ICU住院日及总住院日。

MAIN RESULTS: 主要结果

Enrolment halted on 2nd October 2017 following publication of the Alveolar Recruitment Trial, when 115 of a planned 340 patients had been randomized (57% male, mean age 53.6 years). At 28-days after randomization, there was no difference in ventilator-free days between the maximal lung recruitment and the control ventilation strategies, median [IQR] 16[0-21], n=57 versus 14.5[0-21.5], n=56, P=0.95, mortality 24.6% (n=14/56) versus 26.8% (n=15/56), P=0.79, or the rate of barotrauma 5.2% (n=3/57) versus 10.7% (n=6/56), P=0.32. However, in the intervention group there was reduced use of new hypoxemic adjuvant therapies (i.e. inhaled nitric oxide, extracorporeal membrane oxygenation, prone) (median [IQR] change from baseline 0 (0-1) vs 1 (0-1); P=0.004) and increased rates of new cardiac arrhythmia (n=17, 29% versus n=7, 13%, P=0.03).

本研究于ART试验结果发表后的2017年10月2日终止。计划样本量340名患者,试验终止时115例患者 (57%男性, 平均年龄 53.6 岁) 接受随机分组。随机分组后28天,最大肺复张组及对照通气组无机械通气天数(中位数 [IQR] 16[0-21], n=57 versus 14.5[0-21.5], n=56, P=0.95),病死率(24.6% [14/56] versus 26.8% [15/56], P=0.79)或气压伤发生率(5.2% [3/57] versus 10.7% [6/56], P=0.32)没有显著差异。然而,干预组患者新使用辅助治疗(如吸入NO,ECMO,俯卧位)措施减少(中位数 [IQR] 较基线值变化 0 (0-1) vs 1 (0-1); P=0.004),新发心律失常增加(n=17, 29% versus n=7, 13%, P=0.03)。

CONCLUSIONS: 结论

Compared to control ventilation, maximal lung recruitment did not reduce the duration of ventilation free days or mortality and was associated with increased cardiovascular adverse events but lower use of hypoxemic adjuvant therapies.

与对照通气相比,最大肺复张并不缩短无机械通气天数或降低病死率,且伴随心血管不良事件增加,但减少辅助治疗措施的使用。

Clinical trial registration available at www.clinicaltrials.gov, ID: NCT01667146.

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